Purpose: Red blood cell (RBC) transfusion is frequently given for patients with chronic anemias or acute bleeding after injury or surgery. A CE mark-certified and Food and Drug Administration authorized storage system (Hemanext ONE ® ; Hemanext Inc. Lexington, MA, United States) has been developed to process and store leukocytes-reduced, O 2 /CO 2 reduced RBCs under hypoxic conditions to improve RBC quality for transfusion. This prospective, open-label, single-center pilot safety study investigated the safety of hypoxic RBCs in 2 patient groups: hematological malignancies and acute burns. Patients and Methods: The primary outcome was the number of patients who experienced an adverse event (AE) within 24 hours of transfusion and overall up to 7 days (± 1 day) post-transfusion. Secondary outcomes included changes in hemoglobin (Hb) levels post-transfusion. Results: Twenty patients (10 with hematological malignancies, 10 with surgical bleeding during burn excision) aged 27– 96 years were included (17 males; 8 with hematological malignancies, 9 with burns and 3 females; 2 with hematological malignancies, 1 with burns). All patients in the hematological malignancies group received 2 units of hypoxic RBCs. Patients in the burn group received a mean ±standard deviation (SD) of 1.8 ± 0.4 units of hypoxic RBCs. No AEs related to hypoxic RBC transfusion were reported. The mean ±SD changes in Hb from baseline to 15– 60 minutes post-transfusion were 1.2 ± 0.5 g/dL (hematological malignancies group) and 0.3 ± 1.0 g/dL (burn group). Conclusion: This cohort analysis showed that transfusion with hypoxic RBCs processed with the Hemanext ONE storage system was safe and well tolerated in both cohorts. Keywords: blood transfusion, hypoxic storage, hematological malignancies, transfusion dependent, burns
Reikvam et al. (Mon,) studied this question.